Gastric Cancer
Conditions
Keywords
gastric cancer
Brief summary
The purpose of this study is to evaluate the effectiveness and safety of s-1 plus cisplatin versus 5-FU plus cisplatin as first-line therapy in the treatment of patients with advanced gastric cancer.
Detailed description
This is a randomized, controlled, open-label,multicenter study. Patients are randomized to one of two treatment arms : S-1 plus cisplatin and 5-FU plus cisplatin.
Interventions
S-1:80 mg/m2/day po twice daily on Day 1-21,cisplatin: 20mg/m2 iv on Day 1-4, repeat every 5 weeks. Number of Cycles: until progression or unacceptable toxicity develops.
DRUG5-Fu plus cisplatin
5-Fu 800 mg/m2/d CI 120h ,Cisplatin 20 mg/m2 as a 2 hour i.v. infusion(on day 1 to day 4 )repeat every 4 weeks. Number of Cycles: until progression or unacceptable toxicity develops.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed adenocarcinoma of the stomach with inoperable locally advanced or recurrent and/or metastatic disease. * Male or female. * Age 18 -75. * Previous chemotherapy for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study). * Measurable disease, according to the Response Evaluation Criteria in Solid Tumours(RECIST) * ECOG Performance status 0, 1 or 2 * Haematological, Biochemical and Organ Function: Neutrophil count \>2.0 × 10 9/L, platelet count \> 100 ×10 9/L. Serum bilirubin\< 1.5 × upper limit of normal (ULN); or, AST or ALT \< 2.5 × ULN (or \< 5 × ULN in patients with liver metastases); or, alkaline phosphatase\< 2.5 × ULN (or \> 5 × ULN in patients with liver metastases,Creatinine clearance \> 60 mL/min. * Signed informed consent.
Exclusion criteria
* prior adjuvant/neoadjuvant therapy more than two regiments. * Received any investigational drug treatment within 30 days of start of study treatment. * Patients with active gastrointestinal bleeding. * Neurological toxicity ≥ grade 2 NCI-CTCAE. * Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma. * History or clinical evidence of brain metastases. * Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes. * Pregnancy women. * Subjects with reproductive potential not willing to use an effective method of contraception. * Patients with known active infection with HIV. * Known hypersensitivity to any of the study drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to progression | The time from randomization until objective tumor progression or death |
Secondary
| Measure | Time frame |
|---|---|
| Response rate | 2 months |
Countries
China
Contacts
Primary ContactGuan Zhongzhen, Professor
Backup ContactXu Ruihua, Professor
Outcome results
None listed